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Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer
This study is currently recruiting participants.
Study NCT00477880   Information provided by National Cancer Institute (NCI)
First Received: May 23, 2007   Last Updated: August 11, 2009   History of Changes

May 23, 2007
August 11, 2009
April 2001
April 2010   (final data collection date for primary outcome measure)
Response [ Designated as safety issue: No ]
Response
Complete list of historical versions of study NCT00477880 on ClinicalTrials.gov Archive Site
 
 
 
Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer
Treatment of Ménétrier's Disease With EGF Receptor Blockade

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This clinical trial is studying how well cetuximab works in treating patients with Ménétrier disease at high risk of developing stomach cancer.

OBJECTIVES:

  • Evaluate clinical and biochemical parameter response in patients with Ménétrier disease at high risk of developing gastric cancer treated with cetuximab.

OUTLINE: This is a non-randomized study.

Patients receive cetuximab IV on days 1, 8, 15, and 22. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete a quality of life questionnaire at baseline and during week 4.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

 
Interventional
Treatment, Non-Randomized
  • Gastric Cancer
  • Precancerous/Nonmalignant Condition
Biological: cetuximab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
 
April 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed Ménétrier disease

    • Symptomatic disease, including gastrointestinal symptoms which interfere with daily life

      • Patient is considering surgery
  • Must have failed medical therapy that was given for 6 months
  • No Helicobacter pylori infection

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No NYHA class III-IV cardiovascular disease
  • No clinically unstable pulmonary disease
  • No chronic disease requiring ongoing therapy for stabilization, including any of the following:

    • Uncontrolled diabetes mellitus
    • Malignancy
    • Thyroid disease
    • Hypertension
    • Active infections requiring systemic antibiotics, antivirals, or antifungals
    • Uncontrolled seizure disorder
    • Active neurological disease
  • No unstable coagulation disorders (e.g., hemorrhagic diatheses or active bleeding disorders) that require medical management

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
18 Years to 80 Years
No
 
United States
 
NCT00477880
 
CDR0000546501, VU-VICC-GI-0602, VU-VICC-IRB-000851
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert J. Coffey, MD Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP